Fenwal Secures FDA Clearance for Device Designed to Help Increase Plasma Available for Transfusion

Fenwal Inc., a Fresenius Kabi company, announced today it has received clearance from the U.S. Food and Drug Administration for a functionally closed disposable set used on the Fenwal Autopheresis-C® system to collect plasma for processing into Fresh Frozen Plasma.

The Autopheresis-C system is used worldwide to collect plasma from human donors. Plasma, the liquid portion of blood, is either frozen for future transfusion, or processed by pharmaceutical companies into a range of therapies made from plasma-derived proteins.

The FDA clearance announced today is for a functionally closed disposable set used with the Autopheresis-C system to collect plasma that is processed into Fresh Frozen Plasma for transfusion. The closed design of the new set allows thawed plasma to be stored for up to an additional four days.

“Because of the longer shelf life, this Fenwal set helps increase availability of plasma for transfusion,” said Dean Gregory, president of Medical Devices in North America. “At the same time, this new clearance expands our portfolio of plasma-collection products for blood centers, and responds directly to a need many blood centers have expressed to us for enhanced plasma collection, especially for AB type donors.”

The functionally closed Autopheresis-C disposable set is designed for safety and ease of use with a pre-attached needle and collection containers. The Autopheresis-C system labeling allows for the collection of up to 885 milliliters of plasma from qualifying donors, providing up to four therapeutic doses.

Plasma and plasma-derived proteins are used to treat burn victims, bleeding disorders, human immune deficiencies, and other chronic or genetic disorders. Nearly 5 million units of plasma are transfused annually in the United States. Unlike other blood components, which are stored at room temperature or refrigerated, plasma is frozen and thawed prior to transfusion.